Naturogest 8 % Gel 1.35 gm

Naturogest Gel Overview:

Naturogest Gel, a progestogen (steroid hormone), is used to treat progesterone deficiency by restoring adequate hormone levels essential for implantation and maintaining early pregnancy. It helps manage irregular menstruation caused by hormonal imbalance and is also used in hormone replacement therapy to prevent abnormal uterine lining thickening, reducing cancer risk. By restoring hormonal balance, Naturogest Gel supports menstrual regularity, fertility, and overall reproductive health.

Composition:

Each gram contains- Progesterone (Natural Micronised) 8.0% w/w and Gel base q.s.

Each prefilled applicator contains 1.3 g of gel and delivers 1.125 g of gel containing 90 mg Progesterone.

Uses & Benefits of Naturogest Gel:

• Regulates menstrual cycles and treats heavy bleeding.

• Prevents uterine thickening and restores menstruation in secondary amenorrhea.

• Manages conditions related to progesterone deficiency and supports fertility.

How Naturogest Gel Works:

Naturogest Gel works on the uterine lining and helps establish and maintain pregnancy in infertile women while protecting the uterus from the negative effects of estrogen during postmenopausal treatment. Progesterone mimics the natural hormone's action by binding to progesterone receptors in target tissues, including the uterus, ovaries, and mammary glands.

Naturogest Gel transforms the proliferative endometrium into a secretory endometrium, preparing it for potential implantation. It also helps maintain the uterine lining during the luteal phase of the menstrual cycle and supports early pregnancy by preventing uterine contractions that could lead to miscarriage. The medication alleviates anxiety by metabolizing into allopregnanolone, which has calming effects, while helping regulate the menstrual cycle.

Dosage of Naturogest Gel:

• Usage Directions

Naturogest Gel is intended for vaginal use only, and always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. To use the gel, the prescribed amount is inserted deep into the vagina with a clean finger or an applicator, preferably while lying down to allow proper absorption. It is often recommended to apply the gel at bedtime to minimize leakage. Consult with your doctor or pharmacist if you are not sure.

• Missed Dose:

If you miss a dose of Naturogest Gel, take it as soon as you remember, provided it's not too close to your next scheduled dose. If it's almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Never take a double dose to compensate for the missed one, as this can lead to hormone level fluctuations and increased risk of side effects.

• Overdose:

Overdose of Naturogest Gel is uncommon because it is applied vaginally, but using more than the prescribed amount or applying it too frequently may lead to excessive progesterone absorption. Symptoms of overdose can include dizziness, drowsiness, nausea, abdominal discomfort, mood changes, or breast tenderness. In rare cases, very high progesterone exposure may cause headaches or feelings of weakness. If a significant overdose is suspected, it is important to stop further application and seek medical advice, especially if symptoms become severe or persistent. Always use Naturogest Gel exactly as directed to avoid unnecessary hormonal imbalance.

Contraindications of Naturogest Gel:

Naturogest Gel should not be used in patients with abnormal vaginal bleeding, a history of breast cancer, liver disease, or a recent heart attack, stroke, or blood clot. The medication is also contraindicated in women with known hypersensitivity to progesterone or any component of the formulation.

Other contraindications include active or suspected progestogen-dependent tumors, undiagnosed vaginal bleeding, severe liver dysfunction, and active thrombophlebitis or thromboembolic disorders. Women with a history of depression, epilepsy, migraine, or cardiac dysfunction should use this medication with extreme caution and under close medical supervision. Pregnancy testing should be performed before initiating treatment in women of reproductive age to rule out an existing pregnancy.

Precautions & Warnings of Naturogest Gel:

Before starting Naturogest Gel, inform your healthcare provider about your complete medical history, especially regarding liver disease, kidney problems, diabetes, depression, epilepsy, and any bleeding disorders. Patients with allergies to progesterone, oral contraceptives, hormone replacement therapy, or peanuts should inform their doctor and pharmacist.

Regular medical monitoring is essential during treatment, including periodic blood tests, liver function tests, and gynecological examinations. Women with a history of depression should be closely monitored as progesterone can sometimes worsen depressive symptoms. The medication may cause fluid retention, so patients with cardiac or renal conditions should be carefully monitored for signs of edema or worsening of their underlying condition.

Side Effects of Naturogest Gel:

The most common adverse effects include constipation, bloating, gas, dizziness, headache, breast tenderness, vaginal discharge, and urinary incontinence. Common side effects also include drowsiness and stomach discomfort. Additional side effects may include mood changes, diarrhea, and joint pain, which typically resolve on their own.

Other side effects may include abdominal pain, depression, hot flashes, with frequency typically increasing in the first few weeks and generally decreasing as your body adjusts to the medication. Most side effects are mild and temporary, but you should contact your healthcare provider if they persist or become bothersome. Serious side effects requiring immediate medical attention include chest pain, shortness of breath, severe headaches, vision changes, or signs of blood clots.

Safety Related Concerns of Naturogest Gel:

• Pregnancy

Naturogest Gel, containing progesterone, is often prescribed during early pregnancy to support the uterine lining and help maintain a healthy pregnancy, and when used under medical supervision it is generally considered safe. However, it should only be continued for the duration and dosage recommended by a doctor. Regular monitoring during pregnancy is essential to ensure both maternal and fetal well-being.

• Breastfeeding

During breastfeeding, progesterone from vaginal gel is absorbed in small amounts. However, its use should still be guided strictly by a healthcare professional, as safety depends on the mother’s condition and the reason for treatment. Women should inform their doctor if they become pregnant or begin breastfeeding while using Naturogest Gel, so that the treatment can be adjusted appropriately.

• Alcohol

While there's no direct interaction between Naturogest Gel and alcohol, it's advisable to limit alcohol consumption during treatment. However, alcohol may reduce natural progesterone levels or exacerbate side effects like dizziness, nausea, or drowsiness. Limit alcohol intake or avoid entirely, and if you experience increased side effects after consuming alcohol, discuss this with your healthcare provider

• Using Machinery & Driving

When using Naturogest Gel, you must take care during tasks demanding sharp focus, including Using Machinery & Driving, as it can trigger sleepiness or lightheadedness in certain cases. While not everyone encounters these issues, they might hinder quick responses and clear thinking, especially early in treatment or among those more susceptible. To gauge individual reactions safely, skip such activities initially until effects are predictable, and consult a physician for customized instructions.

• Food Interactions

Naturogest Gel, exhibits no significant food interactions owing to its localized absorption, which limits systemic exposure. Unlike oral progesterone, where grapefruit juice could potentially raise blood levels, this concern is minimal for vaginal use. No dietary restrictions apply, though a balanced intake supports overall hormonal health, consult your physician for individual guidance.

• Drug Interactions

Naturogest Gel has minimal systemic drug interactions due to its localized action and low blood levels. No major pharmacokinetic conflicts are typically reported. However, avoid using other vaginal products (e.g., antifungals like clotrimazole or miconazole) simultaneously, as they may reduce efficacy or cause irritation—space applications by at least 6 hours if approved by your doctor. Inform your provider of all medications, as rare effects from CYP3A4 inducers (e.g., carbamazepine) could lower progesterone levels, or inhibitors (e.g., ketoconazole) might elevate them. Herbal supplements like St. John's wort may also interfere.

Inform your healthcare provider about all medications, supplements, and herbal products you're taking. This includes over-the-counter medications, vitamins, and alternative therapies. Don't start or stop any medications without consulting your healthcare provider.

Storage Instructions:

Store below 25°C. Do not freeze.

Keep the medicine out of reach of children. Don't use tablets that have passed their expiration date or show signs of deterioration such as discoloration, cracking, or unusual odor. Dispose of expired or unused medication according to local guidelines or return it to a pharmacy take-back program.

Additional Notes:

• Regular follow-up appointments with your healthcare provider are essential to monitor treatment effectiveness and adjust dosage if necessary.

• Keep a menstrual diary or symptom log to track changes and side effects for better therapy management.

• Report any unusual symptoms, such as allergic reactions, blood clots, or severe side effects, to your doctor immediately.

• Psychological support may help if experiencing mood-related side effects.

• Adopt healthy lifestyle habits like exercise, stress management, and a balanced diet to optimize outcomes.

Frequently Asked Questions (FAQ):

Q: What is Naturogest Gel used for?

A. This micronized progesterone gel helps maintain hormone equilibrium in females. Doctors often recommend it to normalize periods, boost conception chances by readying the uterine lining, sustain initial pregnancy stages, avert premature delivery, and treat issues such as absent secondary periods or premenstrual discomfort. It can also contribute to replacement therapy for menopause relief or to prevent uterine lining overgrowth.

Q: How should Naturogest Gel be applied?

A. Follow your physician's instructions for vaginal insertion. Employ the included applicator, insert softly in a reclined position, and steer clear of intimacy or rinsing the area for a few hours post-use. Treatment length and amount depend on your specific needs—adhere strictly to the label.

Q: What are the common side effects of Naturogest Gel?

A. Typical mild reactions involve spotting-like discharge, head pain, tiredness, stomach unease, chest sensitivity, or swelling. Most fade over time, but alert your doctor to ongoing problems like intense vertigo or emotional shifts. Occasional fluid buildup might lead to slight weight changes, though this gel form tends to limit such occurrences.

Q: Is Naturogest Gel safe during pregnancy or breastfeeding?

A. When doctor-approved, it's typically low-risk, replicating the body's own progesterone to aid gestation without notable fetal threats. For nursing mothers, trace quantities enter breast milk with minimal infant impact. Verify suitability with your medical expert regardless.

Q: Does Naturogest Gel interact with other drugs or alcohol?

A. Its targeted delivery results in few widespread clashes, but skip overlapping vaginal treatments like yeast creams, and time CYP3A4-altering meds carefully (e.g., seizure drugs might weaken it; antifungals could boost levels). Curb alcohol to prevent hormone dips or added sleepiness—review your full med list with your provider.

Q: Can Naturogest Gel cause drowsiness or affect driving?

A. Some people notice slight sleepiness or unsteadiness, mainly at the start. Hold off on vehicle control, equipment handling, or focus-intensive jobs until your reaction stabilizes. If impaired, talk to your doctor about tweaks.

Q: What if I miss a dose of Naturogest Gel?

A. Use it promptly upon recall, but if the next one's imminent, omit the forgotten one and continue routinely. Resist extra amounts, which could heighten adverse reactions.

Q: Who should avoid Naturogest Gel?

A. Do not use if hypersensitive to progesterone, facing unexplained genital spotting, dealing with or having had hormone-sensitive cancers (breast, womb, cervix), major liver problems, or clotting disorders. Disclose your full background to your clinician prior to use.